US12336532B2 - Insulator for preventing container damage and rupture caused by freezing of aqueous solutions containing biological materials - Google Patents

Insulator for preventing container damage and rupture caused by freezing of aqueous solutions containing biological materials Download PDF

Info

Publication number
US12336532B2
US12336532B2 US17/292,921 US201917292921A US12336532B2 US 12336532 B2 US12336532 B2 US 12336532B2 US 201917292921 A US201917292921 A US 201917292921A US 12336532 B2 US12336532 B2 US 12336532B2
Authority
US
United States
Prior art keywords
ice
crust
container
attenuator device
moldable
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active, expires
Application number
US17/292,921
Other languages
English (en)
Other versions
US20220000097A1 (en
Inventor
Rui DE BRITO ESTRELA
Andreia Filipa SILVESTRE DUARTE
Pedro Gil SENA REGO
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Smartfreez Ltda
Original Assignee
Smartfreez Ltda
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Smartfreez Ltda filed Critical Smartfreez Ltda
Assigned to SMARTFREEZ, LDA reassignment SMARTFREEZ, LDA ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SENA REGO, Pedro Gil, SILVESTRE DUARTE, Andreia Filipa
Publication of US20220000097A1 publication Critical patent/US20220000097A1/en
Assigned to SMARTFREEZ, LDA reassignment SMARTFREEZ, LDA ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: DE BRITO ESTRELA, Rui
Application granted granted Critical
Publication of US12336532B2 publication Critical patent/US12336532B2/en
Active legal-status Critical Current
Adjusted expiration legal-status Critical

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A01N1/10—Preservation of living parts
    • A01N1/14—Mechanical aspects of preservation; Apparatus or containers therefor
    • A01N1/146—Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/065—Rigid ampoules, e.g. glass ampoules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068—Venting means
    • A61J1/2075—Venting means for external venting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/16—Holders for containers
    • A61J1/165—Cooled holders, e.g. for medications, insulin, blood or plasma
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/40—Heating or cooling means; Combinations thereof
    • A61J2200/44—Cooling means

Definitions

  • the present disclosure relates to systems for freezing, transporting, storing and thawing aqueous solutions of biological materials, in particularly those used in chemical, and pharmaceutical processes.
  • this disclosure relates to insulators to prevent uncontrolled freezing and container damage or rupture.
  • Biological materials are produced industrially in large batches that are stored for later use as needed, providing this way great management flexibility.
  • the biological materials are obtained as aqueous solutions, which are stored frozen with two main objectives: increase the shelf-life of the product and facilitate its transport.
  • the produced batches are split in smaller amounts and place inside bottles, carboys and bags for storing, transporting, freezing and thawing.
  • freezing, handling and transportation of containers at low temperature presents several risks, such as the degradation of the biological material and/or container rupture.
  • the physical properties of the plastics materials of the containers may change, leading to their fragility and consequently can reduce the containers' ability to absorb external forces, i.e., shocks without fracturing.
  • the volumetric expansion of the ice inside the containers can cause significant mechanical stress, leading to a container, tubing or connector break.
  • the heat transfer in the top of the containers both by convection and radiation, can also lead to the formation of an ice-crust, consisting on an ice layer at the top of the liquid, at the air interface, in the head-space region of the containers, contributing to the cryoconcentration and increasing pressure in the containers and consequently resulting in their damage or rupture.
  • Rupture or damage to the integrity of the containers is undesirable, as it can compromise sterility or lead to contamination or leakage or loss of the biological material.
  • the storing and transportation processes also present some hazard risks since one is dealing with fragile containers that were previously submitted to the freezing process, which can damage or induce mechanical failure. While it is well known that the containers and freezing technologies currently available do not adequately protect the frozen products, the pharmaceutical industry has not been adequately documented the incidence of containers damage during the freezing process.
  • the document U.S. Pat. No. 7,104,074B2 disclosed a system for freezing, thawing, transporting, and storing biopharmaceutical materials, which includes a container, a supporting structure, a temperature control unit, and a transportation cart.
  • the supporting structure is configured to support a container of biopharmaceutical material and the transportation cart includes channels configured to receive supporting structures, such as frames.
  • the frame is configured to receive and support bags in the vertical position.
  • the document U.S. Pat. No. 9,301,520B2 disclosed a system for cooling, freezing, preserving, processing and thawing biopharmaceutical materials.
  • This system includes a moldable container configured to contain the biopharmaceutical materials and to be supported by a supporting and/or protective structure, such as a holder.
  • the holder may have a pillow-shape and acts as a protector, supporting structure or frame for supporting a moldable container during filling, transport, storage, and/or freezing of biopharmaceutical materials.
  • the document WO2018129576A1 also relates to a housing for a moldable container for transporting liquids, which is at least partially coated with an elastic foam.
  • the present disclosure describes devices for freezing, transporting, storing and thawing aqueous solutions of biological materials aiming to solve the above-mentioned problems.
  • the holder 700 has the heat transfer bottom 702 to considerably accelerating the heat transfer in the bottom of the moldable container 30 , increasing the reproducibility and scalability of freezing and nucleation of the aqueous solution of biological materials.
  • the heat transfer bottom 702 can be made of a metal, alloy or a high thermal conductivity polymer.
  • the heat transfer bottom 702 can hold a contacting fluid to enhance the thermal contact between the heat transfer bottom 702 and the bottom of the moldable container 30 , thus enhancing the reproducibility of the controlled nucleation between several containers and also decreasing the nucleation time.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Environmental Sciences (AREA)
  • Hematology (AREA)
  • Dentistry (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Packages (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
US17/292,921 2018-11-12 2019-11-12 Insulator for preventing container damage and rupture caused by freezing of aqueous solutions containing biological materials Active 2040-07-05 US12336532B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
PT11515218 2018-11-12
PT115152 2018-11-12
PCT/IB2019/059704 WO2020100028A1 (fr) 2018-11-12 2019-11-12 Isolant pour empêcher des dommages et une rupture de récipient provoqués par la congélation de solutions aqueuses contenant des matériaux biologiques

Publications (2)

Publication Number Publication Date
US20220000097A1 US20220000097A1 (en) 2022-01-06
US12336532B2 true US12336532B2 (en) 2025-06-24

Family

ID=68965943

Family Applications (1)

Application Number Title Priority Date Filing Date
US17/292,921 Active 2040-07-05 US12336532B2 (en) 2018-11-12 2019-11-12 Insulator for preventing container damage and rupture caused by freezing of aqueous solutions containing biological materials

Country Status (5)

Country Link
US (1) US12336532B2 (fr)
EP (1) EP3879978B8 (fr)
CN (1) CN112955007A (fr)
CA (1) CA3111607A1 (fr)
WO (1) WO2020100028A1 (fr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB201721824D0 (en) 2017-12-22 2018-02-07 Asymptote Ltd Apparatus and methods relating to freezing at least part of a biological sample
CN114471754A (zh) * 2021-12-27 2022-05-13 利穗科技(苏州)有限公司 一种用于生物材料水溶液的容器
CN115099723B (zh) * 2022-08-24 2022-11-15 巨野恒丰果蔬有限公司 基于数据分析的大蒜精油生产用储存罐风险预测系统

Citations (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4377077A (en) * 1981-07-15 1983-03-22 Biotech Research Laboratories, Inc. Device and method for controlled freezing of cell cultures
EP0718212A1 (fr) 1994-12-20 1996-06-26 Joseph N. Villa Récipient isolé de stockage/transport pour maintenir une température constante
US6209343B1 (en) 1998-09-29 2001-04-03 Life Science Holdings, Inc. Portable apparatus for storing and/or transporting biological samples, tissues and/or organs
EP1302410A1 (fr) 2001-10-10 2003-04-16 delta T Gesellschaft für Medizintechnik GmbH Système pour le transport de marchandises à température constante
US7104074B2 (en) 2001-11-01 2006-09-12 Integrated Biosystems, Inc. Systems and methods for freezing, storing, transporting and thawing biopharmaceutical material
WO2012088311A2 (fr) 2010-12-21 2012-06-28 Savsu Technologies Llc Système de stockage isolé ayant un flux d'énergie thermique équilibré
US20120210734A1 (en) 2011-02-22 2012-08-23 Hoffman Gary A Production and use of high pressure for cryopreservation and cryofixation
WO2014079927A1 (fr) 2012-11-23 2014-05-30 Pamgene B.V. Procédé et système de congélation ultrarapide de tissus
US20140150464A1 (en) * 2010-02-08 2014-06-05 TOKITAE LLC, a limited liability company of the State of Delaware Temperature-Stabilized Storage Systems with Integral Regulated Cooling
EP2772451A1 (fr) 2013-02-28 2014-09-03 Scania CV AB Récipient avec élément d'expansion
US9301520B2 (en) 2007-12-21 2016-04-05 Sartorius Stedim North America Inc. Systems and methods for freezing, storing and thawing biopharmaceutical materials
US20170135337A1 (en) 2013-08-16 2017-05-18 Corning Incorporated Vessels and methods for cryopreservation
WO2017220954A1 (fr) 2016-06-24 2017-12-28 Softbox Systems Limited Système passif de régulation de température pour conteneurs de transport et de stockage
WO2018129576A1 (fr) 2017-01-16 2018-07-19 Single Use Support Gmbh Logement pour contenant flexible
WO2018211437A1 (fr) 2017-05-16 2018-11-22 Smartfreez Lda Système pour la réduction d'échelle de processus de congélation et de décongélation de solutions aqueuses de produits pharmaceutiques thermosensibles
US10897892B1 (en) * 2018-09-17 2021-01-26 Mainstream Engineering Corporation Passively regulated controlled cooling rate vial holding apparatus and method for controlling cooling rates

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9060508B2 (en) * 2012-07-18 2015-06-23 Alex N. Anti High-performance extended target temperature containers

Patent Citations (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4377077A (en) * 1981-07-15 1983-03-22 Biotech Research Laboratories, Inc. Device and method for controlled freezing of cell cultures
EP0718212A1 (fr) 1994-12-20 1996-06-26 Joseph N. Villa Récipient isolé de stockage/transport pour maintenir une température constante
US6209343B1 (en) 1998-09-29 2001-04-03 Life Science Holdings, Inc. Portable apparatus for storing and/or transporting biological samples, tissues and/or organs
EP1302410A1 (fr) 2001-10-10 2003-04-16 delta T Gesellschaft für Medizintechnik GmbH Système pour le transport de marchandises à température constante
US20030072687A1 (en) 2001-10-10 2003-04-17 Dirk Nehring System to transport goods at consistent temperatures
US7104074B2 (en) 2001-11-01 2006-09-12 Integrated Biosystems, Inc. Systems and methods for freezing, storing, transporting and thawing biopharmaceutical material
US9301520B2 (en) 2007-12-21 2016-04-05 Sartorius Stedim North America Inc. Systems and methods for freezing, storing and thawing biopharmaceutical materials
US20140150464A1 (en) * 2010-02-08 2014-06-05 TOKITAE LLC, a limited liability company of the State of Delaware Temperature-Stabilized Storage Systems with Integral Regulated Cooling
US20120325826A1 (en) * 2010-12-21 2012-12-27 Savsu Techonologies Llc Insulated storage system with balanced thermal energy flow
WO2012088311A2 (fr) 2010-12-21 2012-06-28 Savsu Technologies Llc Système de stockage isolé ayant un flux d'énergie thermique équilibré
US20120210734A1 (en) 2011-02-22 2012-08-23 Hoffman Gary A Production and use of high pressure for cryopreservation and cryofixation
WO2014079927A1 (fr) 2012-11-23 2014-05-30 Pamgene B.V. Procédé et système de congélation ultrarapide de tissus
EP2772451A1 (fr) 2013-02-28 2014-09-03 Scania CV AB Récipient avec élément d'expansion
US20170135337A1 (en) 2013-08-16 2017-05-18 Corning Incorporated Vessels and methods for cryopreservation
WO2017220954A1 (fr) 2016-06-24 2017-12-28 Softbox Systems Limited Système passif de régulation de température pour conteneurs de transport et de stockage
WO2018129576A1 (fr) 2017-01-16 2018-07-19 Single Use Support Gmbh Logement pour contenant flexible
WO2018211437A1 (fr) 2017-05-16 2018-11-22 Smartfreez Lda Système pour la réduction d'échelle de processus de congélation et de décongélation de solutions aqueuses de produits pharmaceutiques thermosensibles
US10897892B1 (en) * 2018-09-17 2021-01-26 Mainstream Engineering Corporation Passively regulated controlled cooling rate vial holding apparatus and method for controlling cooling rates

Also Published As

Publication number Publication date
CN112955007A (zh) 2021-06-11
EP3879978B1 (fr) 2025-07-30
EP3879978A1 (fr) 2021-09-22
EP3879978C0 (fr) 2025-07-30
US20220000097A1 (en) 2022-01-06
WO2020100028A1 (fr) 2020-05-22
CA3111607A1 (fr) 2020-05-22
EP3879978B8 (fr) 2025-09-10

Similar Documents

Publication Publication Date Title
US12262709B2 (en) System for scale-down the processes of freezing and thawing aqueous solutions of thermo-sensitive pharmaceuticals
US12336532B2 (en) Insulator for preventing container damage and rupture caused by freezing of aqueous solutions containing biological materials
US8028532B2 (en) Systems and methods for freezing, storing and thawing biopharmaceutical materials
EP3303176B1 (fr) Dispositif et procédé pour le transport de matière sensible à la température
EP2503978B1 (fr) Systèmes et procédés destinés à être utilisés dans la congélation, la fonte et le stockage de matériaux biopharmaceutiques
US9301520B2 (en) Systems and methods for freezing, storing and thawing biopharmaceutical materials
EP2346469B1 (fr) Systèmes et procédés pour le stockage de matériaux biopharmaceutiques
US4565073A (en) Freezing frame for a plasma container
EP2240012B1 (fr) Systemes et procedes permettant de congeler, de stocker et de decongeler des produits biopharmaceutiques
US20110120151A1 (en) Systems and methods for use in freezing, thawing, and storing biopharmaceutical materials
US20220136757A1 (en) Portable air blast system for homogeneous and reproducible freezing and thawing of biological materials
JP2003205016A (ja) 医療用凍結バッグ
KR20190047913A (ko) 아이스팩

Legal Events

Date Code Title Description
FEPP Fee payment procedure

Free format text: ENTITY STATUS SET TO UNDISCOUNTED (ORIGINAL EVENT CODE: BIG.); ENTITY STATUS OF PATENT OWNER: SMALL ENTITY

FEPP Fee payment procedure

Free format text: ENTITY STATUS SET TO SMALL (ORIGINAL EVENT CODE: SMAL); ENTITY STATUS OF PATENT OWNER: SMALL ENTITY

AS Assignment

Owner name: SMARTFREEZ, LDA, PORTUGAL

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:SILVESTRE DUARTE, ANDREIA FILIPA;SENA REGO, PEDRO GIL;REEL/FRAME:057185/0637

Effective date: 20210225

STPP Information on status: patent application and granting procedure in general

Free format text: DOCKETED NEW CASE - READY FOR EXAMINATION

STPP Information on status: patent application and granting procedure in general

Free format text: NON FINAL ACTION MAILED

STPP Information on status: patent application and granting procedure in general

Free format text: RESPONSE TO NON-FINAL OFFICE ACTION ENTERED AND FORWARDED TO EXAMINER

STPP Information on status: patent application and granting procedure in general

Free format text: FINAL REJECTION MAILED

STPP Information on status: patent application and granting procedure in general

Free format text: RESPONSE AFTER FINAL ACTION FORWARDED TO EXAMINER

STPP Information on status: patent application and granting procedure in general

Free format text: ADVISORY ACTION MAILED

STPP Information on status: patent application and granting procedure in general

Free format text: DOCKETED NEW CASE - READY FOR EXAMINATION

STPP Information on status: patent application and granting procedure in general

Free format text: NON FINAL ACTION MAILED

STPP Information on status: patent application and granting procedure in general

Free format text: RESPONSE TO NON-FINAL OFFICE ACTION ENTERED AND FORWARDED TO EXAMINER

STPP Information on status: patent application and granting procedure in general

Free format text: NOTICE OF ALLOWANCE MAILED -- APPLICATION RECEIVED IN OFFICE OF PUBLICATIONS

AS Assignment

Owner name: SMARTFREEZ, LDA, PORTUGAL

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:DE BRITO ESTRELA, RUI;REEL/FRAME:071163/0689

Effective date: 20250519

STCF Information on status: patent grant

Free format text: PATENTED CASE

CC Certificate of correction